Pfizer Inc. announced today that two Phase 3 studies of Sutent® (sunitinib malate) in advanced breast cancer did not meet their primary endpoints. The SUN 1064 Phase 3 study of sunitinib in combination with docetaxel for the first-line treatment of patients with advanced HER-2 negative breast cancer did not show a statistically significant improvement in progression-free survival compared with docetaxel alone. In addition, the SUN 1099 Phase 3 study of sunitinib plus capecitabine, in previously-treated advanced breast cancer patients, did not show a statistically significant improvement in progression-free survival compared with capecitabine alone.
“Sunitinib has been thoroughly evaluated in advanced HER-2 negative breast cancer, and while we are disappointed in the results, these trials have helped us define the limits and opportunities for the compound and better understand the complex biology of this disease”
“Sunitinib has been thoroughly evaluated in advanced HER-2 negative breast cancer, and while we are disappointed in the results, these trials have helped us define the limits and opportunities for the compound and better understand the complex biology of this disease,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit. “Pfizer Oncology is committed to the rigorous evaluation of investigational therapies in breast cancer, which despite recent advancements, continues to claim far too many lives each year.”
There were more adverse events, including serious adverse events, in the investigational arm than in the comparator arm of each study. A continuing analysis of efficacy and safety data will be completed and presented at a medical meeting in the near future.